DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER— 510(k) K925243
Substantially EquivalentDeknatel, Inc.
FDA 510(k) clearance K925243 for DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER, Substantially Equivalent on 1994-07-27. Applicant: Deknatel, Inc.. Device class: 1.
Clearance details
- Applicant
- Deknatel, Inc.
- Product code
- Code GBX
- Device class
- Class 1
- Regulation
- 21 CFR 878.4200
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose-Heredia, CR
Recent devices under product code GBX
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- K964070 — DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG
- K963098 — PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)
- K962856 — PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR
Adverse events under product code GBX
product code GBX- Death
- 16
- Injury
- 583
- Malfunction
- 3,578
- Other
- 1
- Total
- 4,178
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.